Searching for Biomarkers of Metabolic Obesity.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 119
- 试验地点
- 1
- 主要终点
- Analysis of body composition of people with normal and excess body weight (obesity).
研究概览
简要总结
The main aims of the work: Analysis of the concentration of selected pro-inflammatory parameters in blood serum and saliva of people with different distribution of subcutaneous and visceral adipose tissue. Analysis of metabolic obesity biomarkers in saliva and blood serum. Evaluation of new diagnostic methods for the early determination of the risk of metabolic obesity and its complications.
Based on the inclusion and exclusion criteria the observational study was conducted among 119 people (79 women and 41 men). Study group included 79 people (48 women and 31 men with obesity), and control group included 41 people (31 women and 10 men with normal body weight).
The study consisted of three visits. The first included qualification for the study, body composition measurements, ankle-brachial index test and completing the questionnaires and 3-day nutrition diaries. At the second visit blood was collected to conduct the morphological test. At the third visit saliva was collected to determine the proinflammatory cytokine and adipokine concentration.
详细描述
The main aims of the work:
- Analysis of the concentration of selected pro-inflammatory parameters in blood serum and saliva of people with different distribution of subcutaneous and visceral adipose tissue.
- Analysis of metabolic obesity biomarkers in saliva and blood serum.
- Evaluation of new diagnostic methods for the early determination of the risk of metabolic obesity and its complications.
The study protocol was approved by the Bioethics Committee of the Medical University, no. R-I-002/647/2019 and APK.002.39.2021. All participants gave informed written consent to participate in the study before its commencement. The study began in January 2020 and ended in May 2022.
The research was carried out at the Department of Dietetics and Clinical Nutrition (Faculty of Health Sciences of the Medical University of Bialystok), Biochemical Diagnostics Department (University Clinical Hospital in Bialystok), as well as at the Department of Biotechnology (Faculty of Pharmacy with the Division of Laboratory Medicine of the Medical University of Bialystok).
The first visit took place in the Department of Dietetics and Clinical Nutrition at the Medical University of Bialystok. It included qualification for the study based on the inclusion and exclusion criteria, discussion of the purpose of the study and signing the written consent for the study by the participants, as well as information about the protection of their personal data and full anonymity. 200 people volunteered for the study. Based on the inclusion and exclusion criteria the observational study was conducted among 119 people (79 women and 41 men). Each participant received an individual code (e.g. A01, A02, B01, B02 etc.), which was used to identify the participants in further stages of the study.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 20 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •women and men aged 20-55
- •primary obesity
- •certificate from the dentist confirming the absence of periodontitis and inflammation in the oral cavity.
排除标准
- •secondary obesity,
- •type I and II diabetes,
- •exacerbated coronary artery disease,
- •endocrine disorders,
- •eating disorders,
- •pregnancy and lactation period,
- •use of hormonal contraception or hormone replacement therapy, steroid therapy, antiretroviral therapy,
- •surgical or pharmacological history obesity treatment,
- •pacemaker
结局指标
主要结局
Analysis of body composition of people with normal and excess body weight (obesity).
时间窗: 24 months (analyzes were performed throughout the study period).
In order to determine the body composition of the study participants, an electrical bioimpedance body composition analysis was carried out using the InBody 270 (South Korea, Seoul) device, which enabled the assessment of the following parameters: total body fat percentage, total lean body mass percentage, total body fat mass, total skeletal muscle mass, total body water (L), extracellular (L) and intracellular (L) water.
Analysis of differences in the diet of people with normal and excessive body weight (obesity).
时间窗: 24 months (analyzes were performed throughout the study period).
All participants completed 3-day Nutrition Diary.
Analysis of the concentration of selected pro-inflammatory cytokines and adipokines in the saliva of patients with normal and excess body weight (obesity).
时间窗: 24 months (analyzes were performed throughout the study period).
Analysis of the concentration in saliva of MMP-9, MMP-2, IL-6, TNF-α, resistin, IL-1β, IL-23 in patients with normal and excess body weight (obesity).
Analysis of the concentration of selected pro-inflammatory cytokines and adipokines in the blood serum of patients with normal and excess body weight (obesity).
时间窗: 24 months (analyzes were performed throughout the study period).
Analysis of the concentration in saliva of adiponectin, IL-6,TNF-α, MMP-9, MMP-2, resistin, IL-1β, IL-23 in patients with normal and excess body weight (obesity).
Analysis of body composition and adipose tissue redistribution of people with normal and excess body weight (obesity).
时间窗: 24 months (analyzes were performed throughout the study period).
In order to determine the body composition of the study participants an electrical bioimpedance body composition analysis was carried out using the device: BioScan 920-2 (Great Britain, Essex), which enabled the assessment of the following parameters: total body fat percentage, total lean body mass percentage, total body fat mass, total skeletal muscle mass, total body water (L), extracellular (L) and intracellular (L) water. Also, the area of adipose tissue in the abdominal cross-section was determined: visceral (VAT- Visceral Adipose Tissue) and subcutaneous (SAT- Subcutaneous Adipose Tissue), and visceral to subcutaneous fat ratio (VAT / SAT ratio).
Analysis of differences in quality of life of people with normal and excessive body weight (obesity).
时间窗: 24 months (analyzes were performed throughout the study period).
All participants completed The World Health Organization Quality of Life (WHOQOL- BREF) survey.
Analysis of differences in the eating habits of people with normal and excessive body weight (obesity).
时间窗: 24 months (analyzes were performed throughout the study period).
All participants completed "Beliefs and Eating Habits Questionnaire" created by Behavioral Conditions of Nutrition Team Committee of Human Nutrition Science, Polish Academy of Science.
Risk assessment of lower limb atherosclerosis.
时间窗: 24 months (analyzes were performed throughout the study period).
An ankle-brachial index test compares the blood pressure measured at the ankle with the blood pressure measured at the arm was used in the study.
Analysis of differences in physical activity of people with normal and excessive body weight (obesity).
时间窗: 24 months (analyzes were performed throughout the study period).
All participants completed "International Physical Activity Questionnaire - IPAQ".
次要结局
未报告次要终点